Iobenguane I 123

Iobenguane I 123
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Iobenguane I 123 is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Pheochromocytoma and Neuroblastoma

• AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

Congestive Heart Failure

AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.

Limitations of Use:

• In patients with congestive heart failure, AdreView utility has not been established for:

• Selecting a therapeutic intervention or for monitoring the response to therapy;

using the H/M ratio to identify a patient with a high risk for death.

Dosage

• For adults (≥ 16 years of age), the recommended dose is 10 mCi (370 MBq)

Radiation Dosimetry

The estimated absorbed radiation doses to adults from intravenous administration of AdreView are as shown in Table 2:

This image is provided by the National Library of Medicine.

DOSAGE FORMS AND STRENGTHS

• Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Iobenguane I 123 in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Iobenguane I 123 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Pheochromocytoma and Neuroblastoma

• AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

Congestive Heart Failure

AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.

Limitations of Use:

• In patients with congestive heart failure, AdreView utility has not been established for:

• Selecting a therapeutic intervention or for monitoring the response to therapy;

using the H/M ratio to identify a patient with a high risk for death.

Dosage

• For pediatric patients < 16 years of age weighing ≥ 70 kg, the recommended dose is 10 mCi (370 MBq).

• For pediatric patients < 16 years of age weighing < 70 kg, the recommended dose should be calculated according to patient body weight as shown in Table 1. The benzyl alcohol in AdreView may cause serious adverse reactions in premature or low birth-weight infants.

This image is provided by the National Library of Medicine.

Radiation Dosimetry

The estimated absorbed radiation doses for children from intravenous administration of AdreView are as shown in Table 2:

This image is provided by the National Library of Medicine.

DOSAGE FORMS AND STRENGTHS

• Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Iobenguane I 123 in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Iobenguane I 123 in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Iobenguane I 123 in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Iobenguane I 123 in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Iobenguane I 123 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Iobenguane I 123 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Iobenguane I 123 with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Iobenguane I 123 with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Iobenguane I 123 with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Iobenguane I 123 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Iobenguane I 123 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Iobenguane I 123 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Iobenguane I 123 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Iobenguane I 123 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Iobenguane I 123 in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Preparation and Administration

• Inspect the AdreView vial for particulate matter and discoloration prior to administration. Use aseptic procedures and a radiation shielding syringe during administration. Administer the dose as an intravenous injection over 1 to 2 minutes. A subsequent injection of 0.9% sodium chloride may be used to ensure full delivery of the dose.

Monitoring

Radiation Safety

• AdreView emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. AdreView dosing is based upon the radioactivity determined using a suitable calibration system immediately prior to administration.

• To minimize radiation dose to the bladder, prior to and following AdreView administration, encourage hydration to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following AdreView administration.

Thyroid Blockade

• Before administration of AdreView to patients at risk for thyroid accumulation of the drug, administer Potassium Iodide Oral Solution or Lugol's Solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine 123 by the patient's thyroid. Administer the blocking agent at least one hour before the dose of AdreView. Individualize thyroid blockade; for example, the blockade may not be necessary for patients who have undergone thyroidectomy or those with a very limited life expectancy.

IV Compatibility

There is limited information regarding IV Compatibility of Iobenguane I 123 in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Iobenguane I 123 in the drug label.

Pharmacology

There is limited information regarding Iobenguane I 123 Pharmacology in the drug label.

Mechanism of Action

Structure

File:Iobenguane I 12301.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Iobenguane I 123 in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Iobenguane I 123 in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Iobenguane I 123 in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Iobenguane I 123 in the drug label.

How Supplied

Storage

There is limited information regarding Iobenguane I 123 Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Iobenguane I 123 in the drug label.

Precautions with Alcohol

• Alcohol-Iobenguane I 123 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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